At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
PRO044 SC +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/IIa, Open Label, Escalating Dose, Pilot Study to Assess the Effect, Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous and Intravenous Doses of PRO044 in Patients With Duchenne Muscular Dystrophy
In Brief
A Phase 2 clinical trial evaluating PRO044 SC and PRO044 IV for Duchenne Muscular Dystrophy. Completed, enrolled 18 participants across 4 sites in 4 countries.
Detailed Summary
The purpose of this study is to see whether PRO044 is safe and effective to use as medication for DMD patients with a mutation around location 44 in the DNA for the dystrophin protein.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesBelgium, Italy, Netherlands, Sweden
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionMay 2013
Study CompletionOct 2013
TodayJul 2026
First PostedDec 23, 2009
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.5 years ago
Interventions
PRO044 SCdrug
Subcutaneous injection, once a week, for five weeks
PRO044 IVdrug
Intravenous injection, once a week, for five weeks